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Abstract of dissertation entitled

“An Evidence based guideline of using skin-to-skin care during heel prick

procedure in preterm infants”

Submitted by

HON Yuen Lam

for the degree of Master of Nursing

at the University of Hong Kong

in July 2014

With the application of advanced medical knowledge and technology, survival

of preterm infants is plausible under the care in neonatal intensive care unit (NICU).

However, the preterm infants in the NICU are frequently exposed pain, and heel-prick

is the most frequent medical procedure performed. The pain not only affects the

infants’ neurodevelopment, but also provokes emotional distress among the parents,

this leads to maladaptive coping and parental role alteration.

Administration of skin-to-skin care is found to be an effective pain-relieving

intervention during heel-prick as evidenced by six studies systematically reviewed.

This intervention is encouraged to perform during heel-prick in hospital settings in

Hong Kong. In order to facilitate the practice from evidence, the potential of

implementation is investigated. In addition, the findings transferability, feasibility and

cost-benefit of launching the programme are also examined.

Evidence-based guidelines for diminishing heel-prick induced pain for preterm

infants by skin-to-skin care and implementation plan are set up. Stakeholders are

identified and communication strategies are conferred. Moreover, a pilot testing will

be launched on potential users identified within a time schedule and its effectiveness

will be evaluated. It is expected that, through the translational nursing intervention,

heel-prick induced pain on preterm infants can be diminished, with the best evidence

and up-to-date recommendations supported.

An Evidence based guideline of using skin-to-skin care

during heel prick procedure in preterm infants

by

HON Yuen Lam

BNurs. (H.K.U.); RN

A dissertation submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at The University of Hong Kong.

July 2014

i

Declaration

I declare that the dissertation represents my own work, except where due to

acknowledgement is made, and that has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a

degree, diploma or other qualifications.

Signed …………………………………….………….

Hon Yuen Lam

ii

Acknowledgements

I would like to express my deepest gratitude to my supervisor, Dr. Veronica

Lam, for her patience and support throughout the programme. The dissertation would

not be completed without her guidance. I am also grateful to have a group of helpful

classmates who I can learn from and seek constructive advice from without hesitation.

I would also like to take this opportunity to thank my supervisor and

colleagues from the Department of Health, for their support during my study in the

Master of Nursing course at the University of Hong Kong.

Moreover, special thanks should be given to my parents and friends for their

love, and warmly support. Thank you for their understanding and encouragement.

iii

Contents

Page

Declaration i

Acknowledgements ii

Table of contents iii

Chapter 1: Introduction 1

Introduction 1

Background 2

Affirming the Need 4

Research Objectives 7

Research Question 7

Significance of the Problem 8

Chapter 2: Critical Appraisal 10

Search Strategies 10

Search Results 11

Data Extraction and Quality Assessment 11

Summary of Data 13

Synthesis of Data 17

Recommendation of Evidence 20

Chapter 3: Implementation Potential 22

Target Setting and Audience 22

Transferability of the Findings 23

iv

Feasibility 26

Cost and Benefit Ratio 29

Cost 31

Chapter 4: Evidence-based Practice Guidelines 34

Overview of Guidelines 34

Grades of Recommendations 35

Chapter 5: Implementation plan 41

Communication Plan with Potential Users 41

Communication Process 42

Pilot Testing 45

Chapter 6: Evaluation plan 48

Intervention Outcomes and Outcome Measurements 48

Nature and Number of Clients Involved 50

Data Collection 52

Data Analysis 52

Criteria for Effectiveness 53

Chapter 7: Conclusion 54

References 56

Appendices 63

Appendix 1: Table of Search Strategies and Results 63

Appendix 2: Flow Chart of Included and Excluded Studies 64

Appendix 3: Table of Evidence 65

Appendix 4: Quality Assessment 71

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Appendix 5: The Gantt chart for Adopting the Proposed Intervention 73

Appendix 6: Estimated Cost for Skin-to-skin Contact Intervention 74

Appendix 7: SIGN – Level of Evidence and Grades of Recommendations 75

Appendix 8: Questionnaire for Assessing Satisfaction Level of Nursing Staff 76

Appendix 9: Questionnaire for Assessing Satisfaction Level of Participated

Mothers 77

Appendix 10: Premature Infant Pain Profile 78

1

Chapter 1: Introduction

Introduction

Preterm infant is a baby of less than 37 weeks gestational age. According to the

World Health Organization (2012), there is an estimated figure of fifteen million

babies born preterm every year, while this number is increasing. The survival rate has

been increasing progressively under the care in neonatal intensive care unit (NICU),

with the advancements of the knowledge and technology in neonatal care (Martin et

al., 2009). However, the admission of NICU provoked stressful experience in both the

infants and their parents, especially when the infant is in pain. Such stress and pain

are frequently not cared sufficiently in hospitals which results in parental role

alteration and unrelieved pain in infants that is highly associated with detrimental

outcomes and can be life-threatening. Hence, managing infant pain is highly

important for their growth and development, as well as the psychological well-being

of the parents (Franck et al., 2004).

Skin-to-skin contact (SSC), which enables treatment of infants’ pain with

parental involvement, helps to promote bonding and restructure the undesirable

parental experience. With heel pricking to be the most frequent painful event in

hospital, the aim of this study is to investigate the effectiveness of SSC during heel

2

prick and to develop evidence-based guidelines for the implementation in the neonatal

intensive care setting of a local hospital.

Background

Stress in NICU

Parent-infant attachment is a process that begins during prenatal period and

develops during the first twelve months of a child's life; such bonding is broken as the

preterm infant admitted to NICU and induced nervous tension that alters the expected

parental role. These parents commonly reported anxiousness, fear, feelings of

helplessness and loss of control, and worry of the infants' outcome because of their

inability to protect their infants (Gale & Franck, 1998).

For the infants, stress is attributed by pain from medical procedures in addition

to the separation. Carbajal et al. (2008) reported that infants in NICU are subjected to

more than 100 painful procedures in the first two weeks of life and heel prick

accounts for 55-86% of the procedures. Although heel pricking is perceived as the

least painful procedure in NICU, frequent exposure can end up with hazardous effect

on the delicate preterm infants (Akuma & Jordan, 2011).

Consequences of Unrelieved Pain

3

Preterm infants are more vulnerable to stress and have heightened responses to

successive stimuli. The heightened clinical signs can be observed from infant’s

physiological and behavioural reactions. The physiological responses include

increases in heart rate, respiratory rate, blood pressure, intracranial pressure, and

palmer sweating, and decreases in oxygen saturation level, vagal tone, and blood flow

peripheral and cerebral (Johnston, Steven, Yang, & Horton, 1996). Whereas, the

specific behavioral responses refers to facial actions that form a grimace, crying or

body tensing tend to be more to pain (Evans et al., 2005); Johnston et al (1996) also

identified brow bulge, eye squeeze and nasolabial furrow as specific clues of pain in

preterm infants.

In long term, exposure to nociceptive stimuli may increase intracranial pressure

and thus increase the risk of intraventricular haemorrhage, which adversely affects the

brain development of a preterm infant (Anand, 2000). This altered neurodevelopment

may also modify the function of the autonomic system and result in a prolonged state

of hypersensitivity and hyperalgesia (Fitzgerald & Walker, 2009). Furthermore, it is

estimated that 50 to 70% of these infants have developed neurobehavioral deficits and

more serious learning and behavioral difficulties that are often undiagnosed until later

childhood (Pickler et al., 2010).

Skin-to-skin Contact (SSC)

4

Skin-to-skin contact is also recognized as kangaroo care, which diaper-clad

infants put in upright prone position chest-to-chest, skin-to-skin between care-givers’

breasts. It is a care of preterm infants suggested by the WHO (2003) and has showed

its effectiveness in fulfilling the necessity for warmth, breastfeeding, protection from

infection, stimulation, safety and love. What is more is that it can promote baby's

health and allow early bonding.

SSC during heel prick is proved to have powerful effect in reducing crying,

grimacing and resulting in less fluctuation in heart rate; and more notably, this

intervention emphasizes the importance of the parental role that helps reduce stress

and is essential for healthy parenting adaptation, building competence in infant care

and optimize growth and development of infants (JCAHO. 2001).

Affirming the Need

Pain relief is a human right and is a very important aspect of paediatric nursing

care (IASP, 2005). International guidelines have mandated treatments since late 1980;

yet, studies revealed that majority of the preterm infants still did not receive any

treatment to minimize pain (Carbajal et al., 2008).

In Hong Kong, intervention for pain management in NICU remains to be the

use of opioids and is used for critically ill infants only. The use of opioid, though is

5

the standard of pain management, may not be effective on infants (Carbajal et al.,

2008). Regardless of the effectiveness, adverse effect such as the potential cause of

respiratory depression and the significant slower drugs clearance in the preterm infant

has stopped nurses from administrating opioid-based painkillers (Simon & Anand,

2006).

Non-pharmacological methods are accordingly more preferable. Over the decade,

interest in non-pharmacological pain management has increased dramatically and

researches have illustrated varying degrees of efficacy of the interventions.

Significant as the advancement made, knowledge in neonatal pain management has

not been transferred into nursing practice. Having worked in a NICU in Hong Kong,

practice and situation is observed to be similar to what are mentioned, which no

treatment is provided to the infant and their parents were requested to stay away from

their infants during heel prick procedures. This practice may be able to facilitate the

blood sampling process, but then the infants and their parents become more stressful.

Parental Concern and Aspiration

The practice of keeping parents away during procedures may arouse perplexed

thoughts among parents, because of their absence when their infants are exposed to

pain and induced the feeling of inability to fulfill the parental role, such as protecting

6

and comforting the infant; Parents also worried about the consequences of pain on the

infant later development (Gale et al., 2004). SSC during heel prick allows parents

involvement so that parents can have better understanding on the painful event,

promotes parent-infant interaction and supports parents to contend with the stressful

NICU experience (Browne & Talmi, 2005). Though the intervention required parents

to witness their infant in pain, parents reflected that they still hope to have

contribution in easing infants' pain and more positive views about their role

attainment were observed (Gale et al., 2004; Franck et al., 2004).

Barriers for Pain Management

Needs for the intervention are acknowledged, nonetheless, the problem remains

unsolved. Nurses undereducated on pain assessment may be a barrier for proper

management (Olmstead, Scott & Austin, 2010). However, studies revealed that even

nurses educated on pain assessment did not consistently carry out pain management

techniques due to the absence of specific protocols, guidelines and paucity of training

for pain assessment and management (Rieman & Gordon, 2007). In the NICU of

Hospital A, there is also lacking of pain assessment as well as pain management

protocol in some minor procedures, such as heel prick, which implies that pain

treatment is not prioritized. In addition, barriers related to time constraints, work

security and inconsistence in practice may impact nurses’ ability to promote effective

7

management (Ellis et al., 2007). Therefore, it is essential to translate research

knowledge into daily practice with the development of an evidence-based intervention.

Effective pain relieve interventions should be introduced, object to professional and

ethical consideration when the intervention is available.

Research Objectives

1. To conduct a comprehensive literature search

2. To critically assess the literature research papers

3. To summarize, synthesize the literature research papers

4. To work out recommendations using the best evidence available

5. To develop an evidence-based guideline of using skin-to-skin care during heel

prick for preterm infants in Hong Kong

Research Question

Is skin-to-skin contact effective in reducing physiological and behavioural

responses to heel prick in preterm infants?

PICO Components

Population: Preterm infants.

Intervention: SSC during heel prick

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Comparison: Current practice of no interventions or use of other

interventions

Outcome: Reduce infant’s physiological and behavioral responses

Significance of the Problem

Repeated pain stimulation has found to be more harmful on preterm infants,

compare to term infants and older children, owing to their lower pain threshold and

immature systems for stimuli modulation and homeostasis maintenance (Hall &

Anand, 2005). By applying SSC, the health status of preterm infants is improved and

opportunities for early parent-infant attachment are allowed. It is particularly

beneficial to the parents because such attachment encourage empowerment of infant

care so as to enhance competence and confidence for better preparation before

discharge from hospital (DiMenna, 2006).

While the intervention outcome is favorable to the infants and their parents,

SSC does not require any more staff or any special facilities than usual care (WHO,

2003). It is suggested that simple arrangements and guidance are sufficient to ensure

smooth and comfortable process. Besides, as the intervention reduce complications on

infants’ health and enhance readiness for discharge, the duration of hospital stays can

be shortened and thus reduce medical costs.

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Chapter 2: Critical Appraisal

Search Strategies

A comprehensive literature search (Appendix 1 & Appendix 2) was performed

using three electronic databases: PUBMED, CINAHL Plus and Cochrane Library. In

order to include more relevant studies, no limit was set on the publishing year. The

latest electronic search was done on 31st July 2013.

The key search terms used were ‘Skin-to-skin contact’, ‘Kangaroo care’,

‘Kangaroo mother care’, ‘Preterm infant’, ‘Premature infant’, ‘low birth weight infant’,

‘Heel prick’ and ‘Heel lance’. Further search was done with different combination of

the key terms. Manual search was also done by reviewing reference list of relevant

studies.

Inclusion Criteria

• Primary studies on SSC for preterm infants during heel prick procedure

conducted in NICUs or SCBU in hospitals

• Preterm infants born before 37 weeks of gestational age with stable condition

were recruited as subjects

• Studies measure infants’ physiological and behavioural responses as the outcome

Exclusion Criteria

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• Literature that was not human studies was excluded

• Literature prepared in languages other than English and Chinese was excluded

• Literature with no full text available was excluded

Search Results

After combining the key search terms, ten studies were found in PUBMED, none

from CINAHL Plus and seven from the Cochrane Library; seventeen potentially

relevant studies were yielded, while all were written in English. Among the seventeen

studies identified, five were excluded because of duplication. After screening the title

and abstract, six more were excluded with reference to the inclusion and exclusion

criteria. One study was included by manual search but no full text was found for one

study; in total, six eligible studies were included.

All six eligible studies were randomized controlled trails (Castral et al., 2008;

Cong, Ludington-Hoe, & Walsh, 2011; Johnston et al., 2008; Johnston et al., 2003;

Ludington-Hoe, Hosseini, & Torowicz, 2005; Nimbalkar et al., 2013).

Data Extraction and Quality Assessment

The six eligible studies were reviewed for evaluation. All the studies were carried

out in hospital setting. Relevant data were extracted and organized in the table of

evidence which allowed a more systematic analysis of the findings. Citation of the

12

study, study design, patient characteristics, intervention, comparison, length of

follow-up, outcome measures and effect size are the data extracted (Appendix 3). The

evidence level of the studies was graded, in accordance with the seven-level hierarchies

of evidence invented by Melnyk and Fineout-Overholt (2011). Utilizing the

methodology checklist for randomized controlled trials by the Scottish Intercollegiate

Guidelines Network (SIGN, 2012), quality assessment was undergone. The table of

quality assessment result attached to Appendix 4.

Result of Quality Assessment

The six RCTs were assessed and the evidence levels ranged from 1++ to 1-. All of

the selected studies addressed an appropriate and clearly focused question. Four of the

six studies (Cong, Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al.,

2008; Nimbalkar et al., 2013) clearly reported the method of randomization. Five

studies (Cong, Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al.,

2008; Ludington-Hoe, Hosseini, & Torowicz, 2005; Nimbalkar et al., 2013)

adequately reported the method of concealment.

Owing to the involvement of parents and healthcare workers in the process of

SSC, it was difficult to keep blinding. Three studies (Johnston et al., 2003; Johnston et

al., 2008; Nimbalkar et al., 2013) adequately addressed the method of blinding and the

13

blinding method remained to be observer blind. In all of the seven studies, no group

difference was reported between the intervention and the control groups in the pre-test

phase, and the validity and reliability of their outcome measures were all adequately

addressed. The drop-out rate was less than 6%; reasons for the drop out include

mother feeling too nervous about the heel prick procedure and cases discharged

before any heel prick undergone. Two of the studies (Johnston et al., 2003; Johnston

et al., 2008) involved more than one site but no comparable result was reported.

The level of evidence was coded with the SIGN (2012) methodology checklist.

One study (Nimbalkar et al., 2013) was coded 1++ with very low risk of bias. Three

studies (Cong, Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al.,

2008) were coded 1+ and two studies (Castral et al., 2008; Ludington-Hoe, Hosseini,

& Torowicz, 2005) were coded 1- with high risk of bias.

Summary of Data

The six RCTs were published between years 2003 and 2013. Two studies

(Johnston et al., 2003; Johnston et al., 2008) were conducted in Canada, others were

conducted in the United States (Cong, Ludington-Hoe, & Walsh, 2011), Brazil

(Castral et al., 2008), Central America (Ludington-Hoe, Hosseini, & Torowicz, 2005)

14

and India (Nimbalkar et al., 2013). The sample size ranged from 10 (Cong,

Ludington-Hoe, & Walsh, 2011) to 74 (Johnston et al., 2003).

Participant Characteristics

All studies clearly stated the participant characteristics. The participants

recruited were all mother-infant dyads and most of the inclusion criteria were about

the infants’ characteristics. The common inclusion criteria of the preterm infants used

in the studies was gestational age. It ranged from 28 weeks to 36 weeks while infants

with gestational age 32 to 36 weeks were recruited in most of the studies (Castral et al.,

2008; Johnston et al., 2003; Ludington-Hoe, Hosseini, & Torowicz, 2005; Nimbalkar

et al., 2013). Though only one study set criteria on body weight of less than 2500

grams (Nimbalkar et al., 2013), all studies have reported the mean body weight,

ranging from 1421 to 1448.8 grams.

Other inclusion criteria were infants’ Apgar score >6 at 5 minutes (Castral et al.,

2008; Cong, Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al.,

2008; Ludington-Hoe, Hosseini, & Torowicz, 2005) and breathing unassisted (Castral

et al., 2008; Johnston et al., 2003; Johnston et al., 2008; (Ludington-Hoe, Hosseini, &

Torowicz, 2005)

15

For the exclusion criteria, all studies excluded infants with congenital or

neurologic anomaly, with grade III/IV intra-ventricular haemorrhage and those were

receiving or having received analgesics opioids or sedative medications within last

24-48hours. Three studies excluded infants with surgical operation done (Cong,

Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al., 2008).

Intervention Period

The intervention was to provide SSC during heel prick on preterm infants, so as

to reduce their physiological and behavioural responses. The duration of intervention

applied was listed clearly and consisted of three phrases: before heel prick, throughout

the procedure and post-heel prick.

The intervention duration varied from 15 to 180 minutes before heel prick.

Three studies conducted skin-to-skin contact for 15 minutes pre-heel-prick (Castral et

al., 2008; Johnston et al., 2008; Nimbalkar et al., 2013), two studies practised for 30

minutes pre-heel-prick (Cong, Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003)

and one study practised for 180 minutes pre-heel-prick (Ludington-Hoe, Hosseini, &

Torowicz, 2005). All of these durations showed significant effects on infant outcomes.

However, one study has compared duration of 80 minutes to 30 minutes of

skin-to-skin care and discovered that 80 minutes skin-to-skin contact was less

16

effective because of more disruptive arousal from the quiet sleep episode when being

awakened in the sleep cycle, which resulted in infant irritability and crying (Cong,

Ludington-Hoe, & Walsh, 2011).

All studies have the intervention conducted throughout the procedure.

Nonetheless, only four studies stated the duration of skin-to-skin contact

post-heel-prick and the duration were 2 minutes (Castral et al., 2008), 5 minutes

(Johnston et al., 2003), 15 minutes (Nimbalkar et al., 2013) and 20 minutes (Cong,

Ludington-Hoe, & Walsh, 2011).

Outcome Measures

To measure infant’s outcome, premature infant pain profile (PIPP) was employed

in four of the studies. All four studies have obtained a lower mean PIPP score in the

intervention group, ranged from 5.38 to 10.7 while the mean score for control group

ranged from 10.23 to 14.33, meaning that pain was relieved with SSC (Cong,

Ludington-Hoe & Walsh, 2011; Johnston et al., 2003; Johnston et al., 2008;

Nimbalkar et al., 2013).

The two studies that did not utilize PIPP score, measured the changes in heart

rate and oxygen saturation as physiological indicator, and the sleep-wake state and cry

duration were measured as behavioural indicator (Castral et al., 2008; Ludington-Hoe,

17

Hosseini, & Torowicz, 2005). It was discovered that less fluctuation was observed in

heart rate and oxygen saturation. Considering the behavioural indicators, more infants

with skin-to-skin contact stayed in deep sleep before heel prick and fewer infants in

the group cried during the procedure; the cry duration was also shortened.

Apart from the three facial action measured by the PIPP score, three studies

(Castral et al., 2008; Johnston et al., 2003; Johnston et al., 2008) exploited the Neonatal

Facial Coding System (NFCS) to monitor change in facial actions; fewer change was

detected.

Synthesis of Data

Integrating data from the six studies, it can be concluded that SSC during heel

prick is feasible to conduct among the mother-infant dyads. According to the practical

guideline issued by the WHO (2003), SSC is suitable for stabilized preterm infants

who do not entail continuous medical support for vital functions and are not subject to

sudden unexpected deterioration, regardless of intercurrent disease.

Target Participants

With reference to the six studies, selection criteria should be set with the

preterm infant with (1) gestational age greater than or equal to 32 weeks (Castral et al.,

2008; Johnston et al., 2003; Ludington-Hoe, Hosseini, & Torowicz, 2005; Nimbalkar

18

et al., 2013); (2) body weight at least 1400grams as concluded from the mean body

weight of the studies participants; (3) Apgar Score >6 at 5 minutes; (4) without major

congenital anomalies; (5) no suffering from Grade III / IV IVH; (6) not receiving

paralytic, analgesic, or sedative medications; (7) no surgical operation done (Cong,

Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al., 2008); and (8)

breathing unassisted (Castral et al., 2007; Johnston et al., 2003; Johnston et al., 2008;

Ludington-Hoe, Hosseini, & Torowicz, 2005).

SSC Position

The posture of SSC is described in the six studies. All six studies suggested to

have the diaper-clad infant held upright at an angle about 60 between the mother’s

breasts and covered the infant with a blanket (Castral et al., 2007; Cong,

Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al., 2008;

Ludington-Hoe, Hosseini, & Torowicz, 2005; Nimbalkar et al., 2013). Two of the

studies further suggested having the blanket tucked under each side of the mother

(Castral et al., 2007; Johnston et al., 2008) and three studies suggested to have the

mother’s clothes wrapped on top of the blanket (Johnston et al., 2003; Ludington-Hoe,

& Walsh, 2011; Nimbalkar et al., 2013). The mothers’ hands are recommended to

clasp behind infants back (Castral et al., 2007; Johnston et al., 2003; Johnston et al.,

2008; Ludington-Hoe, Hosseini, & Torowicz, 2005; Nimbalkar et al., 2013). In order

19

to minimize uncontrolled variation, the mothers are refrained from touching (Castral

et al., 2007, Johnston et al., 2003) and vocalizing (Castral et al., 2007, Johnston et al.,

2003; Johnston et al., 2008) to the infant throughout the SSC.

SSC Duration

The SSC intervention is suggested to practice before, throughout and after heel

prick procedure. All studies advised to practice SSC throughout the procedure, but the

duration varied for the duration pre- and post-heel-prick.

The effective pre-procedure durations recommended are 15 minutes (Castral et

al., 2007; Johnston et al., 2008; Nimbalkar et al., 2013), 30 minutes (Cong,

Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003) and 180 minutes

(Ludington-Hoe, Hosseini, & Torowicz, 2005). Upon comparison of the effect size, it

is found that 15 minutes of SSC pre-heel-prick had greater impact on reducing the

PIPP scores, length of cry on infants and change in facial actions. For the

post-heel-prick SSC duration, the duration recommended varies from 2 minutes to 20

minutes. Since, all studies advised on different duration and were effective in

stabilizing the infant, recommendation of 15 minutes SSC post-heel-prick by

Nimbalkar et al.(2013) was better suggested as the study has the greatest level of

evidence (1++, with low risk bias).

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To sum up, it is advised to practice SSC 15 minutes before heel-prick,

throughout the procedure and at least 15 minutes afterwards.

Assessment Tool

Several tools were employed to evaluate the outcome measures in the studies.

These tools, including PIPP score, NFCS, length of crying state, sleep-wake state and

the change in vital parameters, are accountable for assessing the physiological and

behavioural responses in preterm infants. Although the validity and internal

consistency of the tools are all guaranteed, majority of the studies have applied the

PIPP scores because it is the only tool enables the formulation of a score derived from

multiple indicators of pain. In such way, comprehensive assessment and clear

comparison of the outcome are allowed, while individual of the components in the

PIPP score are still assessable. Therefore, it is advised to evaluate the infants’

outcome with the PIPP score.

Recommendation of Evidence

In conclusion, it is recommended to implement skin-to-skin contact during heel

prick on stable preterm infants of 32 or more weeks’ gestational age in NICU. Nurses

are advised to take initiation to introduce, educate and assist the parents to perform 15

minutes SSC before heel prick, throughout the blood sampling process and 15

21

minutes afterwards, so as to promote healthy parenting, improve the well-being of the

infants and facilitate their growth and development.

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Chapter 3: Implementation Potential

Skin-to-skin contact (SSC) is known to be beneficial for early establishment of

maternal-infant attachment as well as stabilizing preterm infants in the Neonatal

Intensive Care Units (NICUs) in hospitals. As shown by the reviewed studies, SSC

could also be effective in reducing physiological and behavioral responses in preterm

infants during heel prick procedure. In the following, the potential of implementing

the intervention in a regional hospital in Hong Kong will be investigated. Also, the

transferability of findings, feasibility of launching and the cost-benefit analysis of the

innovation will be discussed.

Target Setting and Audience

The proposed setting (Hospital A) is a teaching hospital of the Medical Faculty

of a local university which is one of the thirty-eight regional public hospitals in Hong

Kong managed by the Hospital Authority. It is also the only regional acute

government-funded hospital with neonatal unit in the cluster (Hospital Authority,

2013). The neonatal unit of Hospital A is a tertiary center accepting referrals from

both public and private institutions. There are 69 beds available, including 20 beds for

NICU and 20 beds for NICU graduates and preterm infants who do not require

intensive care.

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According to the Hospital Authority Statistical Report (2011-2012), the annual

delivery rate in Hospital A was 4,612, with 260 infant born prematurely. These

preterm infants admitted and their mothers are the target of the innovation.

Transferability of the Findings

Similarity of Target Setting

As stated by the literatures found, the six studies were conducted in secondary

level community-based hospital and tertiary level NICUs located in Brazil, the United

States, Canada, Central America and India (Castral et al., 2007; Cong, Ludington-Hoe,

& Walsh, 2011; Johnston et al., 2003; Johnston et al., 2008; Ludington-Hoe, Hosseini,

& Torowicz, 2005; Nimbalkar et al.,2013). The proposed NICU is also a tertiary level

hospital setting; therefore, it is suitable for the innovation to fit in.

Similarity of Target Audiences

The preterm infants admitted to the neonatal unit of Hospital A range from 23 to

37 weeks of gestational age and the gestational age of the targeted infant is similar to

those in the six reviewed studies, which is concluded to be between 32 and 37 weeks.

Most of the participants in the reviewed studies are from Caucasian families,

whereas the target population is preterm infants and their mother admitted to Hospital

24

A and most of them are from Chinese families. The ethnicity of the participants in the

studies and the target population are apparently different, yet, research has shown that

NICU-related stress experienced did not differ among parents of different ethnicity

(Franck et al., 2011). Moreover, participants were reported to be better prepared care

infant pain actively and had more positive views about parental role attainment after

their infant discharged. Thus, the target population can be benefit from the proposed

innovation as suggested by the studies, despite the ethnicity.

Philosophy of Care

People-centred care has always been the mission of the Hospital Authority. It is

to provide quality service in an effective and efficient manner and emphasize on

two-way communication so as to understand and satisfy patients’ needs indispensably

(Hospital Authority, 2013). To facilitate communication with neonates, the care of the

neonatal unit, moreover, stresses on family-centred that embraces a partnership

between staff and families, acknowledging the needs of the infant as well as his

family. (Department of Paediatrics and Adolescent Medicine, 2000).

However, nurses tended to put effort in delivering medical support to the infants

and updating progress to the parents; less attention was paid on managing pain and

strengthening the family unit. With the innovation, pain reduction can be achieved

while maternal-infant attachment is facilitated and family role development is

25

encouraged. The missions of the above parties can, then, be more comprehensively

achieved in the family-centred unit.

Clients to be Benefit

According to the Census and Statistic Department (2013), the crude birth rate in

Hong Kong in 2012 was 12.8 (per 1,000 mid-year population), which was 91558 of

live births and 6-10 in every 100 live births were born prematurely. From the case

report of the target hospital, there were approximately 260 preterm infants admitted

each year and the number is expected to increase in the future with advance medical

achievement. The proposed innovation will benefit preterm infant by treating the

heel-prick pain with the involvement of their mothers, which also help attaining the

parental role. With significant reduction of pain intensity from the proposed

innovation, it is believed that there will be around 200 appropriate preterm infants

benefited per year.

Implementation Plan and Evaluation Time

An organizing committee lead by a nurse specialist will be set-up for the

proposal development. The proposal will then be sent to Chief of Service, Department

Operational Manager and Ward Manager for approval. After obtaining approval, the

committee will take eight weeks to create protocol and four weeks to prepare

equipment and coach staff. A pilot test will be held for twelve weeks and feedbacks

26

will be collected from staff and the mothers on the pilot study. The data entry and

analysis period will last for a one-month. The Gantt chart (Appendix 5) is adopted for

the innovation.

Feasibility

Freedom to Carry Out the Innovation

Hospital A is authorized as one of the baby-friendly hospital initiatives (BFHI)

that promotes, protects and supports breast-feeding. Since preterm infants may have

disadvantage in having direct breast feed, the innovation can provide them

opportunities of early and close contact with their mothers, which is also benefit of

having breast-feed. Moreover, as a teaching hospital of a local university, many

existing practice with evidence-based support are applied in the unit. As the

intervention is supported by quality research with potential benefit shown, gaining

support in translating the innovation will be feasible.

Before the execution of intervention programme, approval will be sought from

the Chief of Service with the potential benefit explained and profits gain on patients

and hospital properly illustrated. After that, nurses can carry out the innovation

accordingly. Termination is allowed when undesirable condition is assessed. Study

has reported drop out of subjects due to nervousness in participating in the heel prick

27

procedure (Johnston et al., 2008). Though the drop-out rate was 1.33% and was not

severe, it is still important to get consent from the mothers and make sure that they

feel comfortable throughout the process.

Implementation of the Innovation

The organizing committee and the nurse specialist will be responsible for the

intervention programme and will obtain approval before implementation. At the

implementation stage, nurses play an important role in facilitating skin-to-skin care

and throughout the blood taking process. Thus, it is important to provide them with

comprehensive work briefing. Emphasis will be stressed on the benefit of the

intervention and techniques required. In addition, nurses will provide counselling

services to the participating mothers during the intervention programme as

psychological support is especially significant. The criteria of the infant selected and

the process will also be introduced, but the recruitment of clients will be done by the

committee. During the recruitment, the committee member will introduce the

innovation and practise SSC with the mothers, so as to familiar with them the skills

and interfere less with nurses’ routine work.

Interfere with Staff Workload

28

The programme will not put great burden to nurses’ daily workload as all nurses

have been trained and have experience in blood-taking, it should not be hard for them

to learn the skill. However, current practice may be partly modified that heel prick

will be done with the presence of the mothers and may also take time to prepare

suitable setting for SSC conduction. As a result, nurses have to accept that the care is

coherent with their usual practice.

Consensus among the Staff

Some nurses may resist the proposed intervention and some may have their own

opinion and viewpoint. Consensus among staff is important, thus, enquiry period will

be arranged to collect comments, modification of the innovation is necessary. Pilot

study should be worked out to test the viability of the innovation.

Equipment and Facilities

In the intervention programme, nurses have to arrange the mother-infant dyads

into the SSC position and perform heel-prick. Prior to implementation, a briefing

session will be held and a function room equipped, screen and projector are required.

Throughout the intervention, armchair, pillows and privacy screens are required to

perform SSC, and alcohol swab, gauze and lancet are required to take heel-prick

blood. Documentation is simple because the neonatal unit is computerized with the

29

aid of the Clinical Information System (CIS), which allowed paperless documentation.

Few items will be added to the comprehensive form and the charting will be neat.

In the neonatal unit, facilities for SSC and equipment for blood-taking are

already available, thus the only costly item is the function room equipped with screen

and projector for the briefing session. Quite a number of nurses can be trained up and

those nurses can benefit many other preterm infant in long term. Printed material can

be prepared for the briefing and for evaluation. Since the clinical setting is spacious

enough and is ready for SSC conduction, it is highly feasible to implement.

Friction within the Organization

The intervention programme will be carried out in the neonatal unit. The

participants will be all nurses and the mother-infant dyads. Friction may appear

between the obstetric unit and the neonatal unit as the mothers participated may be

in-patient of the obstetric unit. Should time crash appear, treatment schedule is

rearranged. Thus, there should have good communication between the two units.

Cost and Benefit Ratio

Potential Risks of Implementation

Nursing staff and parents often perceive that SSC may potentially increase risk

30

of hypothermia or other life threatening conditions such as bradycardia and hypoxia.

Nevertheless, the reviewed studies all prove that SSC does not bring any potential risk

to the preterm infants and their mothers; the care can actually improve the infants’

physical condition (Castral et al., 2007; Cong, Ludington-Hoe, & Walsh, 2011;

Johnston et al., 2003; Johnston et al., 2008; Ludington-Hoe, Hosseini, & Torowicz,

2005; Nimbalkar et al.,2013). In order to reassure the nursing staff and the mothers,

sensors will be attached to the infants throughout the intervention programme so that

vital signs can be closely monitored. The mothers may be still very anxious about the

blood taking process; thus, obtaining verbal agreement from mothers is very

important. To further calm the mothers, demonstration can be shown to them to allow

more concrete idea of the innovation; benefit and risk of not having the innovation

should also be emphasized.

Potential Benefits of Implementation

The preterm-infant-mother dyads can benefit from the innovation as infants are

more stable throughout the blood-taking process. Condition instability should be

avoided whenever possible in preterm infants and pain is one of the stressors that

greatly alter infants’ condition. If the innovation is conducted, pain can be reduced

and the mothers can be empowered to comfort their infants. On the other hand, those

mothers are able to gain confidence in nursing the infant, resulting in less worry in

31

taking care of the infant. Competency in nursing the infant is one of the criteria for

discharge. Therefore, early mother-infant contact can help reducing length of stay

because mothers are more willing to take the infant home and thus reducing the

overall cost of the hospital.

Potential Risk of Maintaining Current Practice

There is not any intervention available to treat procedural pain in the unit yet,

meaning that procedural pain is being ignored and remains untreated currently.

Unrelieved pain is highly associated with detrimental outcomes; brain harm and

neurobehavioral deficits or delays are some examples of the consequences (Pickler et

al., 2010). These deficits included an increase incidence of attention deficit disorder,

anxiety and stress disorders, hyper-vigilance, exaggerated startle response and altered

bio-behavioural response to pain.With such deficits, longer length of stay and more

follow-up session to the paediatric clinic is expected.

Cost

The cost of the intervention programme can be categorized into material cost

and non-material cost. The material cost is the charges for photocopying the

guidelines and questionnaires, whereas the non-material cost refers to the manpower

cost. The cost estimated for the intervention is attached to Appendix 6.

32

As mentioned previously, materials needed are function room, printed notes for

the briefing, evaluation forms, armchairs, pillows, privacy screens and blood-taking

utensils. Function room, arm-chairs, pillows, privacy screens and blood-taking

utensils exist in the unit and no extra pay is required. For this reason, notes and

evaluation forms for the 50 neonatal nurses are the only material cost. It is estimated

to prepare a 2–page notes and a 2-page evaluation form to each nurse, with the

photocopy cost of $0.2 per page. The cost of the printing fee is ($0.2 X 2 + $0.2 X 2)

X 50 = $40. In addition, four copies of the evidence based guideline and a checklist

will be put in the 3 NICU cubicles and at the nursing station. Such cost will be $0.2 X

7 X 4 = $5.6. Therefore, the total cost for the material is $40 + $5.6 = $45.6.

The expenses on non-material items basically come from the charges for

manpower. The implementation of the intervention programme certainly requires the

participation of the nursing staff. However, no extra manpower will be provided.

Nurses may have to spare time for the intervention. Since the interference of the

intervention is minimal to nurses’ work, time cost is mainly spent on the briefing

session, which is a one-off briefing. The briefing session will last for one hour and the

average hourly paid of the nursing staff is $177. There are 50 nurses in the neonatal

unit, thus the total cost of the briefing session is $177 x 50 = $8850.

In conclusion, the total cost of the innovation is the sum of the material cost and

33

the non-material cost, that is $45.6 + $ 8850 = $8895.6.

34

Chapter 4: Evidence-based Practice Guidelines

In consideration of the assessment of implementation potential, it is worth to

practice skin-to-skin contact during heel-prick in the neonatal unit. A clear and

user-friendly evidence-based practice guideline is necessary to guide the practice of

the innovative.

Overview of Guidelines

Guideline Title

Evidence-based guideline of using skin-to-skin care during heel prick in preterm

infants

Intended Users

The users are the nurses working in NICU of Hospital A, who take heel-prick

blood for preterm infants.

Purpose of the Guideline

To promote evidence-based pain-relieving intervention through SSC during heel

prick in preterm infants

To reduce pain and distress for preterm infants during heel prick

Target Population

Mother-preterm-infant dyads, whose infants are

Gestational age greater than or equal to 32 weeks

35

Body weight at least 1400grams

With Apgar Score >6 at 5 minutes

Without major congenital anomalies

Not suffering from Grade III / IV IVH

Not receiving paralytic, analgesic, or sedative medications

No surgical operation done

Breathing unassisted

Outcomes Considered

The major outcome considered is the reduction in Preterm Infant Pain Profile

(PIPP).

Grades of Recommendations

The grades of recommendations by the Scottish Intercollegiate Guidelines

Network (2012) is applied to rate the evidence levels. The rating ranges from A to D

that gives more information to the guideline users on the applicability and

effectiveness of each recommendation in the guideline. The criteria of

recommendations are attached in Appendix 7.

Recommendation 1 – Characteristics of the targeted population

Preterm infants who have a gestational age of at least 32 weeks. (Grade A)

Evidence:

36

Johnston et al. (2003) and Nimbalkar et al. (2013) had proved SSC to be

effective in reducing pain in infants and the infants’ age ranged from 32

weeks to 36 weeks 6 days gestation (1+;1++).

Body weight of the infant is at least 1400grams. (Grade B)

Evidence:

The subjects recruited in the reviewed studies ranged from

1421–1448.8grams and SSC has shown to be effective in reducing pain

among these subjects (Castral et al., 2007; Cong, Ludington-Hoe, &

Walsh, 2011; Johnston et al., 2003; Johnston et al., 2008; Ludington-Hoe,

Hosseini, & Torowicz, 2005; Nimbalkar et al., 2013).

(1-;1+;1+;1+;1-;1++).

Infants are required to have Apgar score >6 at 5 minutes. (Grade B)

Evidence:

A 5-minute Apgar score of 7-10 is considered to be normal; with a small

score obtained, infants are more prone to develop neurologic dysfunction

and may not enable sensation from SSC (Castral et al., 2007; Cong,

Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al.,

2008; Ludington-Hoe, Hosseini, & Torowicz, 2005). (1-;1+;1+;1+;1-)

The infants should be free from major congenital anomalies, not suffering from

37

Grade III / IV IVH and not receiving paralytic, analgesic, or sedative

medications. (Grade A)

Evidence:

Congenital anomalies, irreversible intra-ventricular haemorrhage and

sedative medications can all interfere with the sensory of an infants that

are undesired for SSC (Castral et al., 2007; Cong, Ludington-Hoe, &

Walsh, 2011; Johnston et al., 2003; Johnston et al., 2008; Ludington-Hoe,

Hosseini, & Torowicz, 2005; Nimbalkar et al., 2013).

(1-;1+;1+;1+;1-;1++)

No surgical operation should have been done on the infants before. (Grade B)

Evidence:

Infants with operation done were excluded as pain derived from the

operation may blunt the effect of SSC thus minimized benefit from SSC

(Cong, Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et

al., 2008). (1+;1+;1+)

Infants are breathing unassisted. (Grade B)

Evidence:

There is greater risk of disconnection of the ventilation when performing

SSC on infants with breathing assisted (Castral et al., 2007). (1-)

38

Infants were not intubated or even requiring supplemental oxygen

(Johnston et al., 2003; Johnston et al., 2008; Ludington-Hoe, Hosseini, &

Torowicz, 2005). (1+;1+;1-)

Recommendation 2 - SSC position

Place the diaper-clad preterm infant upright at about 60˚ between mother breasts,

covered the back with a blanket with mother’s hands clasped behind infant’s

back. (Grade A)

Evidence:

Majority of the reviewed studies had suggested the above arrangement to

provide maximal SSC between the dyad (Castral et al., 2007; Cong,

Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al.,

2008; Ludington-Hoe, Hosseini, & Torowicz, 2005; Nimbalkar et al.,

2013). (1-;1+;1+;1+;1-;1++)

Recommendation 3 - Duration for SSC

To perform 15 minutes SSC before heel-prick (Grade A)

Evidence:

The infant remained in SSC position at least 15 minutes prior to heel

lancing procedure had shown to be efficacious in diminishing pain

39

response to heel-prick. (Castral et al., 2007; Johnston et al., 2008;

Nimbalkar et al., 2013). (1-; 1+;1++)

To perform SSC throughout heel-prick (Grade A)

Evidence:

All reviewed studies suggested to provide SSC throughout the heel-prick

process (Castral et al., 2007; Cong, Ludington-Hoe, & Walsh, 2011;

Johnston et al., 2003; Johnston et al., 2008; Ludington-Hoe, Hosseini, &

Torowicz, 2005; Nimbalkar et al., 2013). (1-;1+;1+;1+;1-;1++)

To perform at least 15 minutes after heel-prick (Grade B)

Evidence:

Nimbalkar et al. (2013) suggested the infant to remain in SSC position for

15 min after the heel-prick procedure and mother may allow continuing

SSC even beyond this stipulated time. Since all reviewed studies have

different recommendations on the duration of SSC post-heel-prick,

recommendation of Nimbalkar et al. (2013) is taken because it has the

greatest level of evidence (1++, with low risk bias) among all studies.

Recommendation 4 - Outcome measure

40

Assess infant’s condition by Premature Infant Pain Profile (PIPP) before and

after heel-prick (Grade A)

Evidence:

The PIPP is a multidimensional measure of pain including behavioral,

physiological, and contextual (behavioral state and gestational age)

indicators. Multiple measures of pain response are recommended because

no single response can be considered a gold standard as pain response

systems are dissociated (Cong, Ludington-Hoe, & Walsh, 2011;

Ludington-Hoe, Hosseini, & Torowicz, 2005; Nimbalkar et al., 2013).

(1+;1-;1++)

Four out of the six reviewed studies have concluded their result of pain

response with the PIPP score (Cong, Ludington-Hoe, & Walsh, 2011;

Johnston et al., 2003; Johnston et al., 2008; Nimbalkar et al., 2013).

(1+;1+;1+;1++)

41

Chapter 5: Implementation Plan

Having created the evidence-based practice guideline for skin-to-skin care

during heel-prick on preterm infants, it is essential to build a communication plan in

order to make the implementation successful. The plan includes communication

process with potential stakeholders identified and pilot test conduction before putting

the guideline into practice.

Communication Plan with Potential Users

Identification of Stakeholders

The first step to establish a communication plan is the identification of all

stakeholders. The stakeholders are people who will be involved in the proposed

innovation and thus they are key persons to determine if the proposed innovation can

be implemented and sustained (Melnyk & Fineout-Overholt, 2005). There are three

levels of stakeholders involved: management level, clinical level and client level.

Since the innovation is to be carried out in the neonatal unit of Hospital A, the

management level refers to the administrators of the neonatal department. They are

responsible for judging on the adoption and implementation of the innovation as well

as allocating resources. Hence, approval should be obtained from the administrators.

42

The management level includes the Chief of Service (COS), Consultants, Department

Operation Manager (DOM) and Ward Manager (WM).

The clinical level takes account of all staff working in the neonatal ward and

they must beware of the innovation. The frontline staff consists of the Medical

Officers, Nursing Consultants, Nurse Specialists, Nursing Officers, Advanced

Practice Nurses, Registered Nurses and clerks. The Nurse Specialist will lead the

organizing committee to assess, recruit and coach the mother-preterm-infant dyads to

practice skin-to-skin care. Other nurses are to assist the mothers to provide

skin-to-skin care before heel prick and perform blood taking. They are also key

persons to give comments and feedback in the evaluation. The clerks are responsible

for contacting the mothers to come for skin-to-skin care. The staff consensus and

active involvement can necessarily facilitate and sustain the innovation.

The preterm infants and their mothers play an important role throughout the

process and they are the stakeholders at the client level. Their compliance and

opinions on skin-to-skin care during heel prick will help to improve the innovation.

Though the preterm infants cannot give comments, their mothers can closely observe

the reaction of the infants and reflect their feeling.

Communication Process

43

The purpose of communicating with the identified stakeholders is to introduce

and explain them the innovation, so as to convince them and gain support for

smoother implementation. The process involves setting up an organizing committee

and communication with the stakeholders.

Setting up an organizing committee

There are five committee groups existing in the neonatal unit of Hospital A,

namely Occupation Safety Health Group, Medication Group, Breast Feeding Support

Group, Infection Control Group and the Preterm Infant Support Group. Every nurse is

assigned to one of the groups. Since the skin-to-skin contact innovation is targeting at

the preterm infants and their mothers, all six members of the Preterm Infant Support

Group, the proposer and a nurse specialist will be the committee members who are

responsible for the innovation. In order to gain support and consensus within the

committee, the innovation proposer will share the details and information of the

innovation with the members, mainly on the concern of untreated pain on preterm

infants, inadequacy of current practice and the evidence on the effectiveness of

skin-to-skin care in reducing pain induced from heel-pricking. This process will take

about 2-week and another 4-week will be taken for proposal development.

Communicate with the Administrators

44

Intended for the innovation approval and funding, a proposal, which emphasizes

the idea and rationale behind the innovation with evidence from the reviewed

literature, the potential benefits and budget plan, will be prepared by the organizing

committee. The proposal will be sent to the administrators and presented in one of the

monthly department meetings held by the COS and DOM. The details of the

innovation will be openly discussed to collect feedbacks, comments, as well as

understanding the interest of the senior administrators.

Communicate with the Staff

Once the approval is obtained, the organizing committee will spend eight weeks

in creating the evidence-based practice guideline. Within this period, the committee

will also hold discussion at the nursing staff meeting held by DOM and WM, to

collect nurses’ comments on the innovation. The committee will consider nurses’

concerns and will convince them to accept and support the proposed innovation. Prior

to the implementation of the guideline, a comprehensive briefing will be conducted as

the evidence-based practice guideline is completed. The logistics and benefit of the

intervention will be explained in the briefing, techniques required for SSC and

heel-pricking with the use of the PIPP assessment tool will be demonstrated.

Procedures with related photographs will be featured in staff training and will be

45

distributed to all frontline nurses in the centre. A copy of the guidelines will be kept at

the nursing station.

Nurses will then start assisting the recruited mothers to provide skin-to-skin care

to their preterm infants during heel-prick procedure according to the guideline.

On-site demonstration will be shown by the organizing committee if necessary.

Return demonstration to the organizing committee will be done by the nurses on the

first three attempt of the innovation implementation.

Communicate with the Mothers of the Preterm Infants

Posters showing skin-to-skin care are to be posted on the notice board inside the

neonatal ward. This aims to advertise the innovation and increase the awareness of

providing skin-to-skin care. The mothers of targeted preterm infants will be

approached and the innovation will be explained and the benefit will be stressed by

the committee members. The mothers have the right to decide whether to join the

innovation or not and verbal consent will be obtained from the mothers interested in

the programme. They can withdraw whenever they feel uncomfortable because some

people may feel uneasy with the blood taking procedure.

Pilot Testing

46

A pilot test should be carried out before full implementation of the innovation

so as to allow the feasibility checking of the guideline, feedback collection and

potential barriers or unanticipated difficulties identification (Melnyk &

Fineout-Overholt, 2011). Thus, the pilot test can provide opportunities to refine the

evidence-based practice guideline before wide dissemination of the proposed

guideline.

The target participants in the pilot test will be mother-preterm infant dyads

whose infant’s gestation age are greater than or equal to 32 weeks, body weight

greater than 1400 grams and Apgar Score of 6 or greater at 5 minutes. They should

not have any major congenital anomalies, not suffering from irreversible

intraventricular haemorrhage, nor receiving sedative medications. Infants who have

undergone surgical operation and breathing assisted are also excluded. The pilot test

will last for twelve-week and follow by a four-week evaluation period.

As predicted from the annual admission of 260 preterm infants in Hospital A,

there will be about 60 preterm infants admitted within the twelve-week pilot test

period. Observing the current admitted preterm infants, about 60% of them are

eligible to the inclusion criteria of the innovation. Thus, it is expected to be able to

recruit 36 subjects within the pilot test period.

47

The pilot will begin after all frontline staff has attended the briefing session. In

the pilot test, the organizing committee will recruit the eligible subjects. All nursing

staff will assist the recruited subjects to provide SSC during heel-prick and will assess

infant pain with the PIPP assessment tool.

Evaluation of Pilot Testing

Nurses, who have tried carrying out the innovation, will be invited to fill out a

satisfaction questionnaire (Appendix 8) and to join a focus group interview held by

the organizing committee. The aim of the focus group interview is to explore nurses’

views and experiences in implementing the innovation, and hence, the guideline can

be modified to become more user-friendly. Discussion will be led by the organizing

committee and will be focused on the logistics of the intervention, staff compliance,

strength and weakness of the guidelines and interference caused to ward routine work.

The evaluation of the pilot test will also include the pain response of the

targeted infants and the satisfaction of the mothers. The pain intensity will be

measured with the Premature Infant Pain Profile (PIPP) and recorded in the Clinical

Information System, an existing computerized system for clinical documentation. In

addition, the targeted mothers will be given a questionnaire (Appendix 9), to collect

comments about the innovation.

48

Chapter 6: Evaluation Plan

A systemic plan is necessary to evaluate the effectiveness of the skin-to-skin

innovation for reducing heel-prick induced pain in preterm infants. The plan should

outline how to identify and measure the outcomes, state the nature and number of

clients to be involved and illustrate the data collection and data analysis method.

Intervention Outcomes and Outcome Measurements

Primary Outcome

The ultimate goal for the innovation is to reduce heel-prick induced pain in

preterm infants through providing skin-to-skin contact. The outcome measured is the

Premature Infant Pain Profile (PIPP) (Stevens et al., 1996) for the infants’ pain

intensity determination. The PIPP is a validated behavioural acute pain scale that

examines both behavioural and physiological parameters, and enables more reliable

pain estimation on preterm infants (Ballantyne et al., 1999). The gestational age,

behavioural state, the change of heart rate and oxygen saturation from baseline, and

the duration of time with brow bulge, eye squeeze and a naso-labial furrow observed

are the seven indicators considered. Each of the indicators is interpreted at a

four-point composite pain scale, which results in a PIPP score range between 0 and 21

points; a higher total score indicates more intensive pain (Appendix 10). Using the

49

scale, nurses who are responsible for blood taking, will assess the pre-term infant

condition with PIPP and give a score before and after heel-prick.

Secondary Outcome

Apart from the primary goal of pain reduction, satisfaction among nursing staff

and the targeted mothers are considered to be important as well, because it can affect

the compliance of the intervention. In addition, the compliance rate will also be

calculated from the total number of cases attended to perform the innovation and the

number of eligible cases recorded.

To collect feedback from the participated mothers, a self-reported questionnaire

will be distributed to them after the procedures. The questionnaire consists of two

parts, the first part comprises of ten close-ended questions and opinions are stated on

a five-point Likert-type scale, from strongly disagree (satisfaction level = 1) to

strongly agree (satisfaction level = 5), to indicate the mothers’ satisfaction rates with

the innovation. The second part is open-ended; the mothers can feel free to write

down any opinions towards the new intervention. The questionnaire is attached to

Appendix 9.

For the staff satisfaction, feedbacks will also be collected via questionnaire

(Appendix 8). Similar to that for the targeted mothers, the questionnaire for staff

50

comprises of ten close-ended questions with five-point Likert-type scale options and

spaces for comments. Moreover, the organizing committee will hold group meeting

after the innovation period. Staffs are invited to join the meeting to allow open

discussion on the innovation. The agenda of the meeting will include the effectiveness

and efficacy of the innovation, adequacy of the training given, competency to

implement the new practice and support from the committee.

Nature and Number of Clients Involved

Nature of Clients

The inclusion and exclusion criterion of the mother-preterm-infant dyads is

identical to the criterion of the targets in the pilot test stated previously. All eligible

dyads for the innovation have the pre-term infants’ gestational age greater than or

equal to 32 weeks, body weight greater than 1400 grams and Apgar Score of 6 or

greater at 5 minutes. Besides that the infants’ condition has to be stable, without any

major congenital anomalies, irreversible intraventricular haemorrhage and sedative

medications. Infants having surgical operation done and breathing assisted are

excluded.

Number of Clients Involved

51

In order to estimate the number of samples, the Java Applets for Power and

Sample Size (Lenth, 2011) will be utilized for paired sample t-test. The reason a

paired samples t-test is used is because the scores are for the same sample, which

suggests there is an underlying relationship between the scores. The ultimate outcome

of the intervention is to reduce the pain intensity in preterm infants during heel-prick.

The pain intensity is detected by using PIPP and is measured pre- and post-heel-prick

as the samples undergo usual incubator care as well as skin-to-skin care. The

difference of the PIPP under the two conditions will be matched for further

calculation.

Based on the literature, the effect size are 0.63 (Johnston et al., 2003), 0.5

(Johnston et al., 2008), 1.22 (Nimbalkar et al., 2013) and ranged from 8.83 to 89.84 in

the study of Cong, Ludington-Hoe, & Walsh (2011). Due to great variation noted

among the studies, it may suggest taking the effect size of 0.5 because the sample in

the study fulfilled the criteria in the pilot test and has a high evidence level. Taking

the effect size of 0.5, considering 5% level of significance and with a power of 90%, a

sample size of 44 is needed. The reported dropout rate in the literature ranged from

0% to 6%. 10% dropout rate will be used as protective measure and thus the sample

size will be around 50.

Data Collection

52

Nurses performing heel-prick are required to grade the pain level of the

preterm-infants according to the PIPP; the grading scale is attached to Appendix 10.

From the literature reviewed, the PIPP was found to have significant reduction at 60

to 90 seconds after heel-prick (Johnston et al., 2003) and at 90 seconds after heel

prick (Johnston et al., 2008). Therefore, the pain assessment is suggested to perform

before skin-to-skin contact for baseline taking and 90 seconds after the heel-prick

procedure, so that the point difference can be recorded for analysis.

The questionnaire for satisfaction assessment will be distributed to the

participated mothers after the procedures and to the nurses after the programme.

Comments and feedbacks will be collected for further improvement.

Data Analysis

The Statistical Package for Social Science (SPSS) version 20 will be exploited

to analyze the data collected, including the demographic data of the participants, the

pre- and post-test PIPP and the satisfaction level of nurses and the mothers of the

preterm infants. The demographic data included the gestational age, gender of the

infant and birth weight are collected and the satisfaction survey will be recoded and

analyzed by T-test; whereas, the mean level of the pain intensity on the preterm

infants will be measured by the paired-sample t-test.

53

Criteria for Effectiveness

The guideline is considered effective when the heel-prick induced pain is

reduced through skin-to-skin care. As stated in the literature reviewed, a mean

difference of 2 points in the PIPP score between the usual incubator care and the

skin-to-skin care is considered clinically important (Stevens et al., 1996; Cong,

Ludington-Hoe, & Walsh, 2011; Johnston et al., 2003; Johnston et al., 2008;

Nimbalkar et al., 2013;). Therefore, after comparing the mean PIPP score taken at 90

second post-heel-prick under skin-to-skin care to that of usual incubator care, the new

guidelines can be regard as effective if there is a 2-point difference in the PIPP mean

score.

The compliance and acceptance of the innovation is also significant in deciding

on the innovation effectiveness. The innovation is considered to be effective if the

compliance rate is over 80%. The satisfaction level of nurses and the participated

mothers is assessed by the questionnaire with the five-point Likert-type scale. The

innovation is considered to be effective if 70% of the respondents graded the overall

satisfaction level is equal to or greater than 4.

54

Chapter 7: Conclusion

Infant pain induced by heel-prick, the most frequent pain procedure performed,

is often neglected in the Neonatal unit. Such painful experience provokes stress not

only on the preterm infants, but also on their parents. With a view to the mission of

family-centred care, the Neonatal unit is responsible for acknowledging the needs of

the preterm infants as well as their family by providing ongoing professional support.

Therefore, it is necessary to manage heel-prick included pain with parent

involvement.

Skin-to-skin care during heel-prick allows parent involvement in pain

management that promotes bonding within the mother-preterm-infant dyad. It helps

building up partnership between mothers and nurses and brings about apparent

positive outcomes on preterm infants, parents, nurses and the health care system.

Evidence from the reviewed literature also proved that the skin-to-skin care is

effective and feasible in reducing pain and distress induced from heel-prick procedure

in preterm infants.

With the aim of successful execution of the innovation at the Neonatal unit, the

implementation should be well-planned with clear instruction launched and

development of evidence-based guidelines is required accordingly. Prior to the

implementation, it is necessary to communicate with the stakeholders, and a pilot test

55

should be carried out, in an attempt to test the feasibility and make further

improvements. Lastly, the effectiveness of the innovation should be assessed

according to the evaluation plan.

It is expected that the proposed skin-to-skin care intervention is beneficial to the

preterm infants and their mothers, such that preterm infants’ pain from heel-prick is

minimized.

56

References

Anand, K.J.S. (2000). Effects of perinatal pain and stress. Progress in Brain Research,

122, 117–129.

Auma, O.A., & Jordan, S. (2011). Pain management in neonates: a survey of nurses

and doctors. Journal of Advanced Nursing, 68(60), 1288-1301.

Ballantyne, M., Stevens, B., McAllister, M., Dionne, K., & Jatheck, A. (1999).

Validation of the premature infant pain profile in the clinical setting. Clinical

Journal of Pain (15), 297-303.

Browne, J.V., & Talmi, A. (2005). Family-based intervention to enhance infant-parent

relationships in the neonatal intensive care unit. Journal of Pediatric

Psychology, 30(8), 6667-6677.

Carbajal, R., Rousset, A., Dancan, C., Coquery, S., Nolent, P., & Ducrocq, S. (2008).

Epidemiology and treatment of painful procedures in neonates in intensive care

units. JAMA, 300, 60-70.

Castral, T., Warnock, F., Leite, A., Haas, V., & Scochi, C. (2008). The effects of

skin-to-skin contact during acute pain in preterm newborns. European Journal

of Pain,12, 464–471.

57

Census and Statistics Department (2013). Mid-year population, population growth,

dependency ratios and vital events. Hong Kong Annual Digest of Statistics.

Retrieved November 29, 2013, from

http://www.censtatd.gov.hk/hong_kong_statistics/statistics_by_subject/index.jsp

?subjectID=1&charsetID=2&displayMode=T

Cong, X., Ludington-Hoe, S., & Walsh, S. (2011). Randomized Crossover Trial of

Kangaroo Care to Reduce Biobehavoral Pain Responses in Preterm Infants: A

Pilot Study. Biological Research For Nursing, 13 (2), 204-216.

Department of Paediatrics and Adolescent Medicine (2000). Vision & Mission.

Retrieved February 7, 2014, from http://paed.hku.hk/menu/

DiMenna, L. (2006). Consideration for Implementation of a neonatal kangaroo care

protocol. Neonatal Network, 25(6), 405-412.

Ellis, J., McCleary, L., Blouin, R., Dube, K., Rowley, B., MacNeil, M., & Cooke, C.

(2007). Implementing best practice pain management in a pediatric hospital.

Journal for Specialists in Pediatric Nursing, 12(4), 264-277.

Evans, J., McCartney, E., Lawhon, G., & Galloway, J. (2005). Longitudinal

comparison of preterm pain responses to repeated heelsticks. PediatricNursing,

31 (3), 216-221.

http://www.censtatd.gov.hk/hong_kong_statistics/statistics_by_subject/index.jsp?su

http://www.censtatd.gov.hk/hong_kong_statistics/statistics_by_subject/index.jsp?su

58

Fitzgerald, M. & Walker, S.M. (2009). Infant pain management: a developmental

neurobiological approach, Nature Reviews Neurology, 5, 35-50.

Franck, L.S., Cox, S., Allen, A., & Winter, I. (2004). Parental concern and distress

about infant pain. Archives of Disease Childhood. Fetal and Neonatal Edition,

89, 71-75.

Franck, L.S., Oulton, K., Nderitu, S., Lim, M., , Fang, S., Kaiser, A. (2011). Parent

Involvement in Pain Management for NICU Infants: A Randomized Controlled

Trial. Pediatrics, 128 (3), 510 -518.

Gale, G., Franck, L.S. (1998). Toward a standard of care in the neonatal intensive care

unit. Critical Care Nurse, 18 (5), 62-74.

Gale, G., Franck, L.S., Kools, S., & Lynch, M. (2004). Parents’ perceptions of their

infant’s pain experience in the NICU. Internation Journal of Nursing Studies,

41, 51-58.

Guinsburg, R., Almeida, M., Peres, C., Shinzato, A., & Kopelman, B. (2003).

Reliability of two behavioral tools to assess pain in preterm neonates. Journal of

Sao Paulo Medicine, 121, 72-76.

http://pediatrics.aappublications.org/search?author1=Linda+S.+Franck&sortspec=date&submit=Submit

http://pediatrics.aappublications.org/search?author1=Kate+Oulton&sortspec=date&submit=Submit

http://pediatrics.aappublications.org/search?author1=Sue+Nderitu&sortspec=date&submit=Submit

http://pediatrics.aappublications.org/search?author1=Magdalene+Lim&sortspec=date&submit=Submit

http://pediatrics.aappublications.org/search?author1=Anthony+Kaiser&sortspec=date&submit=Submit

59

Hospital Authority (2011-2012). Hospital Authority Statistical Report. Retrieved

November 30, 2013, from from

http://www.ha.org.hk/upload/publication_15/471.pdf

Hospital Authority (2013). Vision, Mission and Values. Retrieved February 7, 2014,

from

http://www.ha.org.hk/visitor/ha_visitor_index.asp?Content_ID=10009&Lang=E

NG&Dimension=100&Parent_ID=10004&Ver=HTML

International Association for the Study of Pain (IASP), Special Interest Group on Pain

in Childhood. (2005). Children’s pain matters! Priority on pain in infants,

children, and adolescents. Retrieved at http://www.iasp-pain.org/AM/Template.

cfm?Section=2005_2006_Pain_in_Children1&Template=/CM/ContentDisplay.

cfm&ContentID=2993

JCAHO (2001). Retrieved 14 March, 2013 from Joint Commission on Accreditation

of Healthcare Organizations Pain Standards for 2001:

http://www.jcaho.org/standard/pm.html

Johnston, C., Filion, F., Campbell-Yel, M., Goulet, C., Bell, L., McNaughton, K., et al.

(2008). Kangaroo mother care diminishes pain from heel lance in very preterm

neonates: A crossover trial. BMC Pediatrics, 8 (13), 13.

http://www.ha.org.hk/upload/publication_15/471.pdf

http://www.ha.org.hk/visitor/ha_visitor_index.asp?Content_ID=10009&Lang=ENG&Dimension=100&Parent_ID=10004&Ver=HTML

http://www.ha.org.hk/visitor/ha_visitor_index.asp?Content_ID=10009&Lang=ENG&Dimension=100&Parent_ID=10004&Ver=HTML

http://www.iasp-pain.org/AM/Template

60

Johnston, C., Steven, B., Yang, F., & Horton, L. (1996). Developmental changes in

response to heelstick in preterm infants: a prospective cohort study.

Developmental Medicine and Child Neurology, 38 (5), 438-445.

Johnston, C., Stevens, B., Pinelli, J., Gibbins, S., Filion, F., Jack, A., et al. (2003).

Kangaroo Care Is Effective in Diminishing Pain Response in Preterm Neonates.

Archives of Pediatrics & Adolescent Medicine, 157 (11), 1084-1088.

Lenth, R. V. (2011). Java applets for power and sample size Retrieved May, 14th,

2013, from http://homepage.stat.uiowa.edu/~rlenth/Power/

Ludington-Hoe, A., Hosseini, R., & Torowicz, D. (2005). Skin-to-skin Cintact

(Kangaroo Care) Analesia for Preterm Infant Heel Strick. AACN Clinical Issues,

16 (3), 373-387.

Martin, J., Hamilton, B., Sutton, P., Ventura, S., Menacker, F., & Kirmeyer, S. (2009).

Births: Final data for 2006. National Vital Statistics Reports, 57 (7), 1-102.

Melnyk, B., & Fineout-Overholt, E. (2011). Evidence-based practice in Nursing &

Healthcare: A Guide to Best Practice (2nd ed.). Philadelphia: Lippincott,

Williams & Wilkins.

http://homepage.stat.uiowa.edu/~rlenth/Power/

61

Nimbalkar, S., Chaudhary, N., Gadhavi, K., & Phatak, A. (2013). Kangaroo Mother

Care in Reducing Pain in Preterm Neonates on Heel Prick. Indian Journal of

Pediatrics, 80 (1), 6-10.

Olmstead, D.L., Scott, S.D, & Austin, W.J. (2010). Unresolved pain in children: A

relational ethics perspective. Nursing Ethics, 17(6), 695-704.

Pickler, R., McGrath, J., Reyna, B., McCain, N., Lewis, M., & Cone, S. (2010). A

model of neurodevelopmental risk and protection for preterm infants. The

Journal of Perinatal and Neonatal Nursing, 24 (4), 356-365.

Queen Mary Hospital (2011-2012). Department of Paediatrics and Adolescent

Medicine Statistical Report.

Rieman, M., & Gordon, M. (2007). Pain management competency evidenced by a

survey of pediatric nurses’ knowledge and attitudes. Pediatric Nursing, 33(4),

307-312.

SIGN 50: A guideline developer’s handbook. Scottish Intercollegiate Guidelines

Network, 2012.

Simon, S., & Anand, J. (2006). Pain control: opioid dosing, population kinetics and

side-effects. Seminars in Fetal and Neonatal Medicine, 11 (4), 260-267.

62

Stevens, B., Johnston, C., Petryshen, P., & Taddio, A. (1996). Premature infants pain

profile: Development and initial validation. Clinical Journal of Pain, 12(1),

13-22.

World Health Organization (2003). Kangaroo mother care: a practical guide. Geneva:

Department of Reproductive Health and Research, World Health Organization.

World Health Organization (2012, November). Retrieved March 15, 2012, from

Preterm birth: http://www.who.int/mediacentre/factsheets/fs363/en/index.html

http://www.who.int/mediacentre/factsheets/fs363/en/index.html

63

APPENDICES

Appendix 1

Table of Search Strategies and Results

PUBMED

CINAHL

plus

Cochrane

library

Total no.

of studies

Kangaroo care OR Kangaroo

mother care OR Skin-to-skin

contact (S1)

704 77 155 936

Preterm infant OR Premature

infant OR low birth weight

infant (S2)

92438 2891 7517 102846

Heel prick OR Heel lance (S3) 326 11 121 458

Combine S1 AND S2 AND S3 10 0 7 17

Limited to English 10 0 7 17

Topic Screened and Abstract Read

Eliminate Duplicates 10 0 2 12

Eliminated by title and

abstract screening 4 0 2 6

Eliminate no full text available 3 0 2 5

Manual search from references list of relevant studies (+1)

Total studies searched 6

64

Appendix 2

Flow Chart of Included and Excluded Studies

17 potentially relevant studies identified

12 studies were retained for title and abstract screening

6 RCT studies selected

1 study excluded

(no full text available)

6 Randomized controlled trials

5 studies were excluded

(Duplicated reports)

6 studies excluded

(not fulfilling criteria)

1 study included by manual

search

65

Citation Study

Type Patient Characteristics Intervention Comparison

Length

of FU Outcome measures Effect size

Castral, T.C., Warnock, F., Leite, A.M., Haas, V.J., Scochi, C.G.S. (2008). The effects of skin-to-skin contact during acute pain in preterm newborns.

European Journal of Pain, 12, 464–471.

Castral

et al.,

2008

Prospective

RCT

Mother-infant dyads

with infant:

Born between

September 2005 and

May 2006

Born between 30 and

366/7weeks gestation

Apgar score of 6 at 5

minutes

Excluded:

Breathing assisted

With IVH

With Congenital

Nervous system

diseases

Malformation /

neurological damage

Receiving analgesics

opioids

SSC for 15 minutes

before and throughout

heel prick procedure

Diaper-clad infant held

upright at about 60˚

between mother breasts

A blanket was placed

over the infant’s back

and tucked under each

side of the mother

Mothers’ hands are

clasped behind the

infants’ back

NOT allow to touch or

speak to the infants

(n= 31)

Usual incubator care

(IC) for 15 minutes

with Diaper-clad

infant

In lateral decubitus

position

Rolled up in

blankets

(n= 28)

No FU Primary outcomes:

1. Behavioural state

(a) Sleep @ baseline

(b) Crying @ heel-prick

(c) Crying @ heel

squeezing

2. Crying duration

3. HR change (bpm)

(a) at heel-prick

(b) at heel-squeezing

(c) at recovery

4. NFCS mean difference

(a) at heel-prick

(b) at heel-squeezing

(c) at recovery

Secondary outcome:

5.Procedure duration

(second)

1. (SSC vs. control)

(a) 67.7% vs. 64.3%

(b) 51.6% vs. 57.1%

(c) 58.1% vs. 85.7%

2. SSC: 2.5 minutes

IC: 4.8 minutes

-37.41% (p=.024)

3. (a) 2.234 (p<.05)

(b) -8.428 (p<.05)

(c) -0.661 (p<.05)

4.

(a) -1.14 (p<.05)

(b) -1.872 (p<.05)

(c) -0.483 (p<.05)

5. -31.8 (p=.014)

Table of Evidence

Appendix 3

66

Citation Study


Length

of FU

Outcome

measures Effect size

Cong, X., Ludington-Hoe, S.M., & Walsh, S. (2011). Randomized Crossover Trial of Kangaroo Care to Reduce Biobehavoral Pain Responses in

Preterm Infants: A Pilot Study. Biological Research For Nursing, 13 (2), 204-216.

Cong,

Ludington-

Hoe, &

Walsh,

2011

Prospecti

ve RCT

(Crossove

r)

Mother-Preterm infants dyads

with infants:

Born between 30 and 32 weeks

gestation

Apgar scores >6 at 5 minutes

2-9 days of birth

English speaking mother

Excluded:

With major congenital

anomalies

Suffer from severe

periventricular/ IVH (Grade III)

Undergone surgery

Receiving vasopressors,

analgesics, or sedative

medications within 24 hours

Neonatal Skin Condition Score

>6

SSC before and

throughout heel

prick procedure for

(I) 80 minutes

(n=18)

(II) 30 minutes

(n=10)

Diaper-clad infant

held prone &

upright at about

30-40˚ incline

between mother

breasts

A blanket was

placed over the

infant’s back

Usual incubator

care (IC) for

(I) 80 minutes

(n=18)

(II) 30 minutes

(n=10)

In prone position

Nested

Swaddled with a

blanket

At 30˚ incline

No

FU

Mean

PIPP

Study (I) (pre- → post-heel-prick)

SSC: 3.631±2.73→17.05±0.71

IC: 13.25±3.24→16.09±0.8

Study (II) (pre- → post-heel-prick)

SSC: 8.60±4.56→10.60±3.53

IC: 9.75±5.19→14.33±2.89

At post heel prick:

120 seconds (p=.008)

SSC: 5.00 ±1.33 IC: 5.33 ±1.5

Effect size F =17.72


SSC: 4.90±1.37 IC: 5.7±2.71

Effect size F =8.83


SSC: 4.8±1.03 IC: 6.2±3.65

Effect size F =89.84


SSC: 4.5±1.08 IC: 6.0±3.77

Effect size F = 20.93

67

Citation Study


Length

of FU

Outcome


Johnston, C.C., Stevens, B., Pinelli, J., Gibbins, S., Filion, F., Jack, A., et al. (2003). Kangaroo Care Is Effective in Diminishing Pain Response in

Preterm Neonates. Archives of Pediatrics & Adolescent Medicine, 157 (11), 1084-1088.

Johnston

et al.,

2003

Prospective

RCT,

Crossover

Mother-infant dyads with

infants:

Born between 32 and 366/7

week gestation

Apgar scores >6 at 5 mins

Within 10 days of birth

Mother willing and able to

hold infant in Kangaroo

position

Excluded:

Breathing assisted

Have congenital anomalies

Grade III or IV IVH /

subsequent periventricular

leukomalacia

Undergone surgery

Receiving paralytic analgesic

or sedative medications

within 48 hours

SSC for 30 minutes

before, throughout and

5mins after heel prick

procedure

Diaper-clad infant held

upright, at an angle

about 60 ° between the

mother’s breast

A blanket placed over

the infant’s back with

mother’s clothes

wrapped

Others’ hands are

clasped behind the

infants’ back

Refrain from touching

head

Refrain from

vocalizing

(n=74)

Usual incubator care

(IC) with infants in

prone position,

swaddled with a

blanket for 30

minutes before the

heel prick

(n=74)

No FU 1. PIPP

(95%C.I.)

2. Facial

action

(NFCS, %)

1. At Post-heel-prick

30 seconds (p=0.04)

SSC: 10.1 (9.1, 11.1)

IC: 11.6 (10.7,12.4)

Mean difference=1.5

60 seconds (p=0.002)

SSC: 10.7 (9.7, 11.8)

IC: 12.9 (12.1,13.8)

Mean difference= 2.2

90 seconds (p=.02)

SSC: 10.3 (9.6, 11.5)

IC: 12.1 (11.1, 13.2)


120 seconds (p=.37)

SSC:10.7 (8.9, 11.2)

IC: 10.1 (9.5, 11.9)


Effect size = 0.63

2. -20 (p<.005)

68

Citatio

n

Study


Length

of FU

Outcome


Johnston, C.C., Filion, F., Campbell-Yel, M., Goulet, C., Bell, L., McNaughton, K., et al. (2008). Kangaroo mother care diminishes pain from heel

lance in very preterm neonates: A crossover trial. BMC Pediatrics, 8, 13.

Johnston

et al.,

2008

Prospective

RCT

Mother-Preterm infants dyads

with infants:

Born between 280/7

and 316/7

weeks gestational age

Apgar scores >6 at 5 minutes


Mothers willing and able to

hold their infants in kangaroo

care position

Excluded:

Breathing assisted

with major congenital

anomalies

Suffer from Grade III / IV

IVH or subsequent

periventricular leukomalacia

Undergone surgery

Receiving paralytic,

analgesic, or sedative

medications within 48 hrs

(n=61)

SSC for 15

minutes before and

throughout heel

prick procedure

Diaper-clad infant

held upright at

about 60˚ between

mother breasts

A blanket was

placed over the

infant’s back and

tucked under each

side of the mother

Mothers’ hands

are clasped behind

the infants’ back

allow to speak to

the infants

(n=61)

Usual incubator

care (IC) of

infants in prone

position,

swaddled with a

blanket

(n=61)

Not

stated

Primary

outcomes:

1.Mean PIPP

(95% CI)

2. HR change

(bpm)

3. SpO2 change

(%)

4. Facial

expression

(NFCS, %)

1. At post-heel-prick

30 & 60 seconds

Not Significantly lower

90 seconds (p <.001)

SSC: 8.871 (7.852, 9.885)

IC: 10.677 (9.563, 11.79)

Difference =1.806


SSC: 8.855 (7.447, 10.26)

IC: 10.21 (9.03, 11.389)

Difference =1.355

Effect size = 0.5

2. -6 (p<.05)

3. -2 (p<.05)

4. -50 (p<.05)

69

Citation Study


Lengt

h of

FU

Outcome


Ludington-Hoe, A.M., Hosseini, R., & Torowicz, D.L. (2005). Skin-to-skin Cintact (Kangaroo Care) Analesia for Preterm Infant Heel Stick. AACN

Clinical Issues, 16 (3), 373-387.

Ludington

-Hoe,

Hosseini

&

Torowicz,

2005

RCT,

Crossover

Mother-infant dyads with

infant:

Born <37 weeks gestation

Apgar score of 6 at 5

minutes

Excluded infant with:

Breathing assisted within 4

days before data collection

Congenital or neurologic

anomaly

Active sepsis

Grade III/IV IVH

Dysmorphic features

Having received analgesics/

sedatives within last 24

hours

Maternal substance abuse

Intravenous line

On continuous feeding

SSC for 180

minutes before and

throughout the

procedure, and 15

minutes after the

heel prick

diaper-clad infant

held upright, at an

angle about 60 °

between the

mother’s breasts

A blanket placed

over the infant’s

back with

mother’s clothes

wrapped

Mothers’ hands

are clasped behind

the infants’ back

(n=23)

Usual incubator

care (IC) of

diaper-clad

infants in prone

position,

swaddled with a

blanket for 180

minutes before

procedure

(n=23)

No

FU

1. Heart rate change

(bpm)

2. Behavioural state

(a) Deep-sleep @

baseline

(b) Crying @ heel

prick

3. Cry duration

(second)

(pre- → post-heel-prick)

1. Effect size F = 3.54, p=.042

[SSC] Gp. A: 158.2 → 161.14

Gp. B: 157.8 → 159.78

[IC] Gp. A: 147.21 → 166.35

Gp. B:151.85 → 160.44

2. (SSC vs. IC)

(a) 88.54% vs.18.26%

Mann Whitney U = 2.89,

p ≤.04

(b) 64.95% vs. 92.00%

Mann Whitney U = 1.73,

p≤.05

3. Effect size F= 5.20, p= .01

[SSC] Gp. A: none → 2.03

Gp. B: 2.33 → 3.84

[IC] Gp. A: 2.44 → 4.01

Gp. B: 2 → 3.22

70

Citation Study

Type Patient Characteristics Intervention

Compari

son

Length

of FU

Outcome


Nimbalkar, S.M., Chaudhary, N.S., Gadhavi, K.V., & Phatak, A. (2013). Kangaroo Mother Care in Reducing Pain in Preterm Neonates on Heel Prick.

Indian Journal of Pediatrics, 80 (1), 6-10.

Nimbalkar

et al., 2013

RCT,

Crossover

Mother-infant dyads with infant:

BW<2500 gram,

Born between 32 and 366/7

weeks

gestation


Vitally stable

Mother willing and able to hold

their neonates in kangaroo

position

Excluded:

Breathing assisted (except

CPAP)

With clinically evident

neurological signs

Having received analgesics/

sedatives within last 24 hours

Fed within last 30 minutes

(n=50)

SSC contact for 15

minutes before and

throughout the

procedure, and 15

minutes after the

heel prick

Diaper-clad infant

held upright, at an

angle about 60 °

between the

mother’s breasts

A blanket placed

over the infant’s

back with mother’s

clothes wrapped

Mothers’ hands are

clasped behind the

infants’ back

Usual

incubator

care (IC)

of infants

in prone

position,

swaddled

with a

blanket

for 15

minutes

before

procedur

e

Not

stated

1. Mean PIPP (SD)

PIPP for Individual

components (score:

0-3)

(a) Heart Rate

change

(b) SpO2 change

(c) Behavioral

change

1.

SSC: 5.38 (3.25)

IC: 10.23 (4.59)

Mean difference: 4.85

Effect size = 1.22 p=.0001

(a)

Mean difference = 0.58

p<.001

Effect size = 0.75

(b)


p=.02

Effect size = 0.326

(c)


p<.001

Effect size = 2.5

71

Appendix 4

Quality Assessment

Castral et

al., 2008

Cong,

Ludington-Hoe,

& Walsh, 2011

Johnston

et al.,

2003

Johnston

et al.,

2008

Ludington-H

oe, Hosseini,

& Torowicz,

2005

Nimbalkar

et al., 2013

Section 1: Internal validity

1.1 The study addresses an appropriate and clearly focused question. +++ +++ +++ +++ +++ +++

1.2 The assignment of subjects to treatment groups is randomized. ++ +++ +++ +++ ++ +++

1.3 An adequate concealment method is used. - +++ +++ +++ +++ +++

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation. - + +++ +++ - ++

1.5 The treatment and control groups are similar at the start of the

trial. +++ +++ +++ ++ +++ +++

1.6 The only difference between groups is the treatment under

investigation. +++ +++ ++ +++ +++ +++

1.7 All relevant outcomes are measured in a standard, valid and

+++ +++ +++ +++ +++ ++

72

reliable way.

1.8

What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

0% 0% 0% 1.33% 0% 6%

1.9 All the subjects are analyzed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis) - - - - - -

1.10 Where the study is carried out at more than one site, results are

comparable for all sites. NA NA - - NA NA

*Well covered (+++) Adequately addressed (++) Poorly addressed (+) Not addressed/ Not reported (-) Not applicable (NA)

Section 2: Overall assessment of the study

2.1

How well was the study done to minimize bias?

Code ++, +, or –

1- 1+ 1+ 1+ 1- 1++

2.2

Taking into account clinical considerations, your evaluations of the

methodology used, and the statistical power of the study, are you

certain that the overall effect is due to the study intervention?

YES YES YES YES YES YES

2.3 Are the results of this study directly applicable to the patient group

targeted by this guideline? YES YES YES YES YES YES

**Coding system: Good quality (1++) Fair quality (1+) Poor quality (1-)

73

Appendix 5

The Gantt chart for Adopting the Proposed Intervention

Phase

Week

1

|

2

3

|

4

5

|

6

7

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Committee set-up &

proposal development

Obtaining approval

Protocol creation

Staff coaching &

equipment preparation

Pilot Test

Evaluation

Appendix 6

Estimated Cost for Skin-to-skin Contact Intervention

Table 1 Cost estimated for the intervention

Category Items Price per unit Quantity

Amount

(HKD)

Material cost 2-page briefing Notes

$0.2/page

50 20

2-page evaluation form 50 20

6-page evidence based

guideline 4 4.8

1-page checklist 4 0.8

Non-material

cost Manpower for the

briefing session $177/ hour 50 8850

Total 8895.6

75

Appendix 7

SIGN – Level of Evidence and Grades of Recommendations

Levels of evidence

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a

very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk

of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++

High quality systematic reviews of case control or cohort or studies High

quality case control or cohort studies with a very low risk of confounding or

bias and a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of

confounding or bias and a moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a

significant risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

Grades of recommendations

A

At least one meta-analysis, systematic review, or RCT rated as 1++, and

directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly

applicable to the target population, and demonstrating overall consistency

of results

B

A body of evidence including studies rated as 2++, directly applicable to

the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C

A body of evidence including studies rated as 2+, directly applicable to the

target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

76

Appendix 8

Questionnaire for Assessing Satisfaction Level of Nursing Staff

(1)

Strongly

disagree

(2)

Disagree

(3)

Neutral

(4)

Agree

(5)

Strongly

agree

1. The guideline is easy to understand.

2. The training received is adequate.

3. You are competent to implement the

intervention.

4. The intervention is properly

arranged.

5. The pain assessment form (PIPP) is

easy to use.

6. The workload is affordable.

7. The committee is supportive

throughout the program.

8. The intervention is beneficial to the

babies.

9. The intervention is helpful to relieve

the anxiety and distress of parents

during heel-prick.

10. Overall, you are satisfied with this

intervention.

*Please tick the appropriate answer.

Other comments or suggestions:

__________________________________________________________________

__________________________________________________________________

__________________________________________________________________

77

Appendix 9

Questionnaire for Assessing Satisfaction Level of Participated Mothers

(1)

Strongly

disagree

(2)

Disagree

(3)

Neutral

(4)

Agree

(5)

Strongly

agree

1. The explanation provided by the

nurse is easy to understand.

2. The explanation provided by the

nurse is adequate.

3. The nurses are knowledgeable

and helpful in answering the

enquiries about the intervention.

4. The intervention is properly

arranged

5. The practice of skin-to-skin

contact is easy to learn.

6. You feel comfortable during the

skin-to-skin contact.

7. Nurses are supportive throughout

the innovation.

8. The intervention is beneficial to

your baby

9. The intervention is helpful to

relieve your anxiety and distress

level during heel-prick

10. Overall, you are satisfied with

this intervention

*Please tick the appropriate answer.

Other comments or suggestions:

__________________________________________________________________

__________________________________________________________________

__________________________________________________________________

78

Appendix 10

Premature Infant Pain Profile

an evidence based guideline of using skin-to-skin care ...nursing.hku.hk › dissert › uploads ›...

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